A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)
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ClinicalTrials.gov Identifier: NCT05600777 |
Recruitment Status :
Recruiting
First Posted : October 31, 2022
Last Update Posted : February 15, 2024
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Sponsor:
Bellus Health Inc. - a GSK company
Information provided by (Responsible Party):
Bellus Health Inc. - a GSK company
Tracking Information | |||||||||
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First Submitted Date ICMJE | October 18, 2022 | ||||||||
First Posted Date ICMJE | October 31, 2022 | ||||||||
Last Update Posted Date | February 15, 2024 | ||||||||
Actual Study Start Date ICMJE | January 13, 2023 | ||||||||
Estimated Primary Completion Date | September 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
24-Hour Cough Frequency [ Time Frame: Week 24 ] Assessed using an ambulatory cough monitor
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2) | ||||||||
Official Title ICMJE | A Phase 3, 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough, Including Unexplained Chronic Cough | ||||||||
Brief Summary | This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC). | ||||||||
Detailed Description | The primary efficacy objective is to assess the effect of BLU-5937 on 24-hour cough frequency in adults with refractory chronic cough (including unexplained chronic cough) at 24 weeks. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Refractory Chronic Cough | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
825 | ||||||||
Original Estimated Enrollment ICMJE |
675 | ||||||||
Estimated Study Completion Date ICMJE | June 2026 | ||||||||
Estimated Primary Completion Date | September 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Australia, Czechia, Germany, India, Korea, Republic of, New Zealand, Slovakia, Taiwan, United Kingdom, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05600777 | ||||||||
Other Study ID Numbers ICMJE | 221851 BUS-P3-02 ( Other Identifier: Bellus Health Inc ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Bellus Health Inc. - a GSK company | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Bellus Health Inc. - a GSK company | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Bellus Health Inc. - a GSK company | ||||||||
Verification Date | February 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |